Velocity Pharma LLC

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Velocity Pharma LLC, FEI 2000044401, at 210 Sea Lane, Farmingdale, NY from November 3 to December 14, 2023, after an FDA inspection revealed violative conditions at Kilitch Healthcare India Limited, a contract manufacturing organization (CMO) used to manufacture ophthalmic drugs for Velocity Pharma LLC.

The FDA inspection of this foreign facility revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR Parts 210 and 211), causing these drug products to be adulterated, including within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Because these products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health, these drug products are also adulterated within the meaning of section 501(a)(2)(A) of the FD&C Act, 21 U.S.C. 351(a)(2)(A).

The inspection of your facility revealed that you operate as a distributor of certain Equate, Rite Aid, CVS, Up&Up, Velocity Pharma, Leader, Rugby, and other brand name eye drop products. Your receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c), and your introduction into interstate commerce of adulterated drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

We reviewed your December 29, 2023 response to our Form FDA 483 in detail.

An inspection at Kilitch Healthcare India Limited (“Kilitch”) was conducted by FDA from October 12 to 20, 2023, and revealed insanitary conditions and numerous CGMP violations. These violations include but are not limited to poor aseptic practices for the manufacture of sterile drugs; inadequate media fill program and airflow visualization studies; fabrication and alteration of microbiology laboratory records; and microbial recoveries of incubating samples from ISO 5 manufacturing areas. These CGMP violations render the products manufactured by Kilitch adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act.

On October 23, 2023, Kilitch was placed on Import Alert 66-40 and recalled all drug products within expiry on November 15, 2023. On March 28, 2024, Kilitch received a warning letter (Warning Letter #320-24-29). As a distributor of Kilitch products and their registered U.S. Agent, FDA sent you a copy of the warning letter issued to Kilitch.

(b)(4)

An inspection at (b)(4) was conducted by FDA from (b)(4), and revealed numerous CGMP violations. These violations include but are not limited to poor aseptic practices for the manufacture of sterile drugs; fabrication of microbiology laboratory records; microbial recoveries of incubating samples from ISO 5 manufacturing areas and sterility tests exhibiting turbidity during incubation; inadequate media fill program and airflow visualization studies; and use of ripped and visibly dirty gowning in the aseptic processing areas. These CGMP violations render the products manufactured by (b)(4) adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act.

On (b)(4), (b)(4) was placed on Import Alert (b)(4) and recalled all drug products within expiry on (b)(4). On (b)(4), (b)(4) received a warning letter (Warning Letter #(b)(4)).

Your firm utilized CMOs to manufacture your ophthalmic drug products; however, your firm failed to have adequate procedures to ensure all ophthalmic drug products produced for your firm met appropriate quality attributes. You also failed to have adequate supplier qualification procedures to ensure that the drug products received from Kilitch and (b)(4) were manufactured in compliance with CGMP prior to being distributed in the United States.

Our inspection of your firm and review of your import records indicated that you use Kilitch, FEI 3011853060, and (b)(4), FEI (b)(4), as your CMOs. You received and delivered into interstate commerce ophthalmic drug products that were found to be adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act, which is a violation of sections 301(a) and 301(c) of the FD&C Act.

Provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of sections 301(a) and 301(c) of the FD&C Act, 21 U.S.C. 331(a) and 331(c). Items in your plan should include a full evaluation of your supplier and CMO qualification program, including a plan to conduct periodic audits of your suppliers and CMOs. Provide your evaluation of your current suppliers and CMOs.

Your firm’s records for the distribution of finished drug products are deficient. For example, during the inspection of your facility, you provided distribution records that were missing addresses, batch numbers, and quantities shipped from your facility.

FDA held a teleconference with your firm and your CMO, Kilitch Healthcare India Limited, on October 25, 2023. During this call, FDA informed you and Kilitch that our inspection revealed that the products produced at Kilitch do not meet CGMP requirements and are considered adulterated. Neither you nor Kilitch made a commitment to take market action during this discussion. Kilitch insisted that product testing was adequate to overcome the observed CGMP deficiencies. FDA disagreed with this position and reiterated the significant concerns with the products produced at the facility, as described in the warning letter issued on March 28, 2024.

Due to the delay in recall decision by Kilitch, FDA ultimately issued its own public notice on October 27, 2023 (https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye).

Despite numerous attempts by the Agency to obtain a recall decision, Kilitch did not initiate a recall until November 15, 2023 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential), approximately three weeks after the teleconference. As a distributor of Kilitch Healthcare India Limited products in the U.S. market, you failed to take action to remove adulterated products from the market, including your own-label Velocity Pharma products. This is in sharp contrast to the retailers who took immediate action after notice from FDA that their products are adulterated.

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs you deliver into interstate commerce are not adulterated. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to: ORAPharm1_Responses@fda.hhs.gov. Identify your response with FEI 2000044401 and ATTN: Compliance Officer Sena G. Dissmeyer.